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Fuse
ENDOCHOICE, INC. · Model SCT-468-02 · UDI-DI 00840253111173
FDF
Prescription
10
510(k) clearances
78,289
Adverse events (63 deaths)
25
Recalls
76
Facilities
Description
Reusable Water Bottle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-02 | Olympus Corporation of the Americas | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.